A Randomized, Double-Blind, International Multicenter, Phase III Study to Evaluate the Anti-Tumor Efficacy and Safety of Serplulimab or Placebo in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer
A Randomized, Double-Blind, International Multicenter, Phase III Study to Evaluate the Anti-Tumor Efficacy and Safety of Serplulimab or Placebo in Combination With Chemotherapy and Concurrent Radiotherapy in Patients With Limited-Stage Small Cell Lung Cancer
This study is a randomized, double-blind, multicenter, phase III clinical study to compare the clinical efficacy and safety of Serplulimab + chemotherapy+ concurrent radiotherapy vs chemotherapy+ concurrent radiotherapy in subjects with Limited-Stage Small Cell Lung Cancer.
Eligible subjects in this study will be randomized to Arm A or Arm B at 1:1 ratio.
Arm A (Serplulimab arm): Serplulimab + chemotherapy(Carboplatin/Cisplatin-Etoposide)+concurrent radiotherapy; Arm B (placebo arm): Placebo + chemotherapy(Carboplatin/Cisplatin-Etoposide)+concurrent radiotherapy; The 4 stratification factors for randomization include: ECOG PS (0 or 1), staging (I/II or III), radiation fraction (bid or qd), and region (Asia or non-Asia).
Inclusion Criteria:
Exclusion Criteria:
Elmhurst, New York 11373, United States
Vienna, 1210, Austria
Vienna, 1210, Austria
Guangzhou, Guangdong 510000, China
Luoyang, Henan 471000, China
Wuhan, Hubei 430030, China
Wenzhou, Shanghai Municipality 200032, China
Hangzhou, Zhejiang 310003, China
Hangzhou, Zhejiang 310009, China
Ostrava-Poruba, 570852, Czechia
Ostrava-Poruba, Czechia
Ostrava-Vitkovice, 703 00, Czechia
Ostrava-Vítkovice, 703 00, Czechia